Validation and Assessment of Novel Morphology-Voltage-P-w... | NCT06779513

Studies
Validation and Assessment of Novel Morphology-Voltage-P-wave Score for Diagnosing Left Ventricular Diastolic Dysfunction in Patients With Hypertension

NCT06779513

Sponsor

Universitas Diponegoro

Status

Recruiting

Last Update Posted

Jan 16, 2025Actual

Enrollment

50Estimated

Phase

Not provided

Conditions

Hypertension

Interventions

Echocardiohraphy

Countries

Indonesia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2024Actual

Primary Completion Date

Dec 31, 2024Actual

Completion Date

Mar 15, 2025Estimated

First Submitted Date

Jan 11, 2025

First Submission Date that Met QC Criteria

Jan 11, 2025

First Posted Date

Jan 16, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 11, 2025

Last Update Posted Date

Jan 16, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Sodiqur Rifqi, Principal Investigator; Former of Head of Department of Cardiovascular Medicine Faculty of Medicine Universitas Diponegoro, Universitas DiponegoroPrincipal Investigator

Lead Sponsor

Universitas DiponegoroOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study aimed to assess and validate the diagnostic utility of a novel Morphology-Voltage-P-wave Score (MVP Score) in identifying left ventricular diastolic dysfunction among patients with hypertension.

Researchers will collect information of patient with hypertension and underwent transthoracal echocardiography assessment. The data consist of demographic data, clinical presentation, laboratory, and echocardiography result were collected by two investigators. Then, the data was analyzed by using IBM SPSS Statistics v26.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patient with LVDD		Investigators will assess MVP score by reviewing patient 12-lead ECG. Furthermore, the MVP score will be analyzed with echocardiography result.	Diagnostic Test: Echocardiohraphy
Patient without LVDD		Investigators will assess MVP score by reviewing patient 12-lead ECG. Furthermore, the MVP score will be analyzed with echocardiography result.	Diagnostic Test: Echocardiohraphy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Echocardiohraphy	Diagnostic Test	Transthoracal echocardiography for diastolic function assessment	Patient with LVDD Patient without LVDD

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Diastolic Dysfunction	Diastolic Dysfunction found in transthoracal echocardiography assessment	Up to 1 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Essential hypertension

Exclusion Criteria:

Secondary or resistant hypertension
LVEF<55%
Congenital heart disease
Infiltrative cardiomyopathy
Coronary artery disease
Chronic kidney disease
Valvular heart disease
Bundle branch block
Arrhythmia

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Patient with essential hypertension who came to out hospital

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Leo Deddy Pradipta	Contact	+6281316499074		dancingdeagle@gmail.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Dr. Kariadi Central General Hospital	Recruiting	Semarang	Central of Java		Indonesia

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D006973	Hypertension

Ancestor Terms

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided